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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, external body, negative pressure, adult (cuirass)
510(k) Number K895849
Device Name RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Applicant Contact EUGENE N SCARBERRY
Correspondent
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668
Correspondent Contact EUGENE N SCARBERRY
Regulation Number868.5935
Classification Product Code
BYT  
Date Received10/03/1989
Decision Date 12/22/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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